MAUDE Adverse Event Report: ARTHREX, INC. PIN GUIDE, UINVERS VAULTLOCK GLENOID, MD; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PIN GUIDE, UINVERS VAULTLOCK GLENOID, MD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a shoulder arthroplasty procedure, both the vault lock medium pin guide, ar-9215-4cgpp, and vault lock medium trial, ar-9236-02pp, were broken.The pin won't slide through pin hole and the trial center peg snapped off inside patient.The peg was removed and the case was completed with no adverse effect to the patient.Additional information provided 07/20/2020: the peg was retrieved; surgeon had to drill around it to loosen it, then used a grasper to retrieve it.The snapped off peg was lost after it was retrieved from patient.
Additional Manufacturer Narrative
Complaint confirmed, the pin hole was found to be damaged, causing it to be undersized.The undamaged section was found to meet dimensional specifications.A likely cause of the event is user-applied mechanical forces.

• Brand Name: PIN GUIDE, UINVERS VAULTLOCK GLENOID, MD
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10366779
• Report Number: 1220246-2020-01997
• Device Sequence Number: 16955657
• Product Code: MDM
• UDI-Device Identifier: 00888867239005
• UDI-Public: 00888867239005
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PIN GUIDE, UINVERS VAULTLOCK GLENOID, MD
• Device Catalogue Number: AR-9215-4CGPP
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other